A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
NCT ID: NCT07144280
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
680 participants
INTERVENTIONAL
2025-09-29
2032-03-10
Brief Summary
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Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PF-08046054 monotherapy
PF-08046054 monotherapy
PF-08046054
Antibody Drug Conjugate
Participants will receive PF-08046054, administered as an IV infusion.
Docetaxel monotherapy
Docetaxel monotherapy
Docetaxel monotherapy
Participants will receive Docetaxel, administered as an IV infusion.
Interventions
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PF-08046054
Antibody Drug Conjugate
Participants will receive PF-08046054, administered as an IV infusion.
Docetaxel monotherapy
Participants will receive Docetaxel, administered as an IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
3. Participants who have NSCLC with known AGAs are permitted (eg, estimated glomerular filtration rate (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations).
4. Able to provide any of the following tumor tissues for biomarker analysis:
* Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
* Fresh tissue from a tumor lesion, if medically feasible.
5. Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-L1 or PD-1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
* Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-L1 or PD-1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
* Must have received at least 1 approved AGA-targeted therapy and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
* May have received PD-1 or PD-L1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Exclusion Criteria
2. Active central nervous system (CNS) lesions are excluded. Active is defined as untreated or symptomatic requiring corticosteroids \>10 mg/day of prednisone equivalent within the previous 14 days.
Participants with clinically inactive, definitively treated brain metastases (surgery and/or radiotherapy) are eligible if they meet the following criteria:
* The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days (if requiring steroid treatment).
* No evidence of clinical and radiographic disease progression in the CNS for ≥28 days after definitive radiotherapy and/or surgery.
* The use of corticosteroids at higher dose occurring ≥28 days prior to the Screening visit unless it is intermittent use for other medical conditions and allowed as a concomitant therapy.
3. Participants with a history of leptomeningeal metastasis are excluded.
4. Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
5. Previous receipt of an Monomethyl auristatin E (MMAE)-containing agent or prior docetaxel.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alabama Oncology
Alabaster, Alabama, United States
Alabama Oncology
Bessemer, Alabama, United States
Alabama Oncology-
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois Cancer Specialists
Chicago, Illinois, United States
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States
CHRISTUS St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
White Plains Hospital
White Plains, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology- Central South.
Austin, Texas, United States
Texas Oncology Central South
Austin, Texas, United States
Texas Oncology- Central South.
Austin, Texas, United States
Texas Oncology - Central South (Renfert Way)
Austin, Texas, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology - Dallas (Sammons)
Dallas, Texas, United States
Texas Oncology- Central South
Harlingen, Texas, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
Texas Oncology
McAllen, Texas, United States
Texas Oncology- Central South
Waco, Texas, United States
Texas Oncology-Central South
Waco, Texas, United States
Texas Oncology - Gulf Coast
Webster, Texas, United States
Texas Oncology - Central South
Weslaco, Texas, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
McGill University Health Centre
Montreal, Quebec, Canada
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Henan Cancer Hospital
Zhengzhou, , China
Rabin Medical Center
Petah Tikva, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
National Hospital Organization Kochi National Hospital
Kochi, Kochi, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
National Hospital Organization Beppu Medical Center
Beppu-shi, Oita Prefecture, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, Poland
Ad-Vance Medical Research
Ponce, , Puerto Rico
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [chungbuk], South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-kwangyǒkshi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Universitario Virgen de Valme
Seville, , Spain
Changhua Christian Hospital
Changhua County, Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2025-521281-97-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5851005
Identifier Type: -
Identifier Source: org_study_id
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